Comparing a new procedure to medication for treating GERD

Anti-reflux Mucosal Valvuloplasty Versus Proton Pump Inhibitors for the Treatment of Patients With Gastroesophageal Reflux Disease in a Tertiary Healthcare Center in China: Study Protocol for a Randomized Controlled Trial

This study is testing a new procedure for GERD to see if it can help patients feel better than just taking medication.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06348420 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in patients with gastroesophageal reflux disease (GERD) who are currently treated with proton pump inhibitors (PPIs). Under general anesthesia, patients undergo an endoscopic procedure where a segment of mucosa at the esophagogastric junction is reconstructed to form a mucosal flap. The study aims to determine if this surgical approach can provide better outcomes compared to ongoing PPI therapy. Patients will be monitored for symptom relief and any complications following the procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with specific types of hiatal hernias and recurrent GERD symptoms despite PPI treatment.

Not a fit: Patients with a BMI over 35, Barrett's esophagus, or severe esophageal motility disorders are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could offer a more effective long-term solution for GERD patients who do not respond adequately to PPIs.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving GERD treatment outcomes through surgical interventions.

Eligibility criteria

Inclusion Criteria:

* 18-60 years of age;
* Hiatal hernia ≤ 2 cm;
* Sliding hernia ≤ 2 cm;
* Recurrence of GERD symptoms after cessation of PPIs;
* On daily PPI for ≥1 year or twice daily PPI for at least 8 weeks;
* Esophagitis (Los Angeles Classification) Grade B, C, or D;
* Hill's flap valve grade ≤ III;
* Observation of distal esophageal pH \< 4 on at least 1-2 days within a 7-day period, with a percentage exceeding 5.3%;
* Normal or near-normal esophageal motility;
* Lower esophageal sphincter pressure (LESP) ranging between 5-15 mmHg;
* DeMeester score ≥ 14.7 or total reflux episodes exceeding 73;
* Completion of a signed informed consent form.

Exclusion Criteria:

* BMI \> 35 kg/m2;
* ASA \> II;
* Barrett's esophagus;
* Hiatal hernia \> 2 cm;
* Esophagitis (Los Angeles Classification) Grade A or No esophagitis；
* Hill's flap valve grade \> III；
* Peptic ulcer disease;
* Primary esophageal motility disorders such as achalasia;
* Severe gastroparesis;
* History of previous esophageal or gastric surgery, including ARMS or ARMA;
* Uncontrolled systemic diseases;
* Gastric outlet obstruction;
* Pregnancy or planning to become pregnant.

Where this trial is running

Jinan, Shandong

• Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: jiaoyang j lu

Conditions: Gastroesophageal Reflux Disease, Endoscopic anti-reflux, Proton pump inhibitor, Randomized controlled trial, Gastroesophageal reflux disease